Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit recallZ-0744-2020 · Axis-Shield Diagnostics, Ltd. · initiated Sep 16, 2019
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Axis-Shield Diagnostics, Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
FDA root cause category: Under Investigation by firm
What the company is doing
Urgent Medical Device Correction notification letters dated 9/16/19 were sent to customers. Necessary Actions Immediately discontinue use of the affected lots listed and switch to the alternate material lot(s) you may have available in your laboratory. Immediately destroy any remaining inventory of the affected lots listed according to your laboratory procedures. Complete and return the accompanying verification form Immediately order replacement material(s) if you do not have unaffected material available. Please retain this letter for your laboratory records.
Recall details
- Recall number
- Z-0744-2020
- Status
- Open, Classified
- Initiated by the company
- Sep 16, 2019
- Recalling firm
- Axis-Shield Diagnostics, Ltd.
- Quantity
- 740 total
- Product code
- LPS
- FDA submissions
- K083222
- Distribution
- US Nationwide distribution in the states of CA, KY.
Product description
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.
Code information (models, lots, serial numbers)
UDI: 05055845400183; Lot Number 902924815
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit FHRWR1000Axis-Shield Diagnostics Limited1 recall0 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K083222 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit FHRWR100Axis-Shield Diagnostics Limited · Calibrator, Secondary1 recall0 reports
- Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent FHBC100/B08176Axis-Shield Diagnostics Limited · Calibrator, Secondary1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 84043).
- Z-0742-2020 · Open, ClassifiedAxis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of havin…
- Z-0743-2020 · Open, ClassifiedAxis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of havi…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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